Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was conducted 5/10/21 at Kenneth R Beer Md Pa, a clinical laboratory in West Palm Beach, Florida. Kenneth R Beer Md Pa is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the noncompliance. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency attestation sheets and interview with the Laboratory Director, the Laboratory Director failed to sign the attestation sheets for five out of five events reviewed (API Microbiology 2019 3rd Event, 2020 1st, 2nd, and 3rd Events, and 2021 1st Event). The findings included: Review of the API Microbiology proficiency records for (API Microbiology 2019 3rd Event, 2020 1st, 2nd, and 3rd Events, and 2021 1st Event) revealed the Laboratory Director had not signed the attestation statements. Interview on 5/10/21 at 10:05 a.m., the Laboratory Director stated he did not know he had to sign the attestation statements. D2039 MYCOLOGY CFR(s): 493.827(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) record review and interview, the laboratory failed to participate in proficiency testing that resulted in a score of zero (0) percent in Microbiology for 2 (2020 2nd Event and 2020 1st Event) out of 5 (2019 3rd Event 2020 1st, 2nd, and 3rd Events, and 2021 1st Events). The findings included: Review of the API records for the 2020 2nd Event and 2021 1st Event Microbiology showed the laboratory received a score of 0% for Potassium Hydroxide (KOH) testing . Notes on the API "Performance Summary" sheet stated "Failure to Participate". Interview on 5/07/21 at 10:15 a.m., the Laboratory Director stated he did not participate in 2020 2nd Event due to COVID and did not notify API and did not participate in the 2021 1st Event. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with the Histotechnologist, the laboratory failed to ensure the Laboratory Director performed the twice a year accuracy verification testing for two out two years (2019 - 2021) for Scabies testing in the subspecialty of Parasitology. The findings included: Review of Proficiency Testing records revealed there was no documentation of the peer review for Scabies test for the Laboratory Director for two out of two years ( 2019 - 2021). Interview on 2/04/20 at 10:00 a.m., the Histotechnologist confirmed the Laboratory Director did not perform the twice a year accuracy verification testing because the Laboratory Director had not had any patients with scabies testing. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) record review and interview with Laboratory Director, there was no documentation to indicate that the Laboratory Director ensured that